Remote Prenatal Care for Pregnancy

Overseen By Rachel Gross, MD, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Severe illness, Living in shelter, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28-42 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering prenatal care remotely through the StEP:Prenatal program. The researchers aim to compare this approach to regular in-person prenatal care regarding diet, lifestyle, and overall pregnancy outcomes. The study targets individuals who are pregnant, in their first trimester, and plan to receive care at Bellevue Hospital. Participants should speak English or Spanish and have access to a smartphone or internet device. Those with severe illnesses or living in shelters are not eligible. As an unphased trial, participation offers a unique opportunity to contribute to innovative prenatal care solutions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since conditions like diabetes, hypertension, and depression are not excluded, it seems likely that you can continue with those treatments.

What prior data suggests that the StEP:Prenatal intervention is safe for remote prenatal care?

Research shows that remote prenatal care is generally safe, particularly for pregnancies that are not high-risk. This method can reduce the need for in-person visits without causing harm. The StEP:Prenatal program in this trial includes remote sessions with dietitians to help improve diet and lifestyle. Previous studies have not found any major negative effects from this type of care. Data indicates it is well-received. Participants in similar programs have improved their diet and lifestyle habits without major safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Remote Prenatal Care approach because it integrates traditional prenatal care with digital health support through the StEP:Prenatal program. Unlike typical prenatal care, which might involve routine in-person visits, this approach offers up to eight additional remote sessions. This digital support can provide more personalized and frequent touchpoints, potentially improving outcomes by ensuring that expectant mothers have regular access to guidance and support without the need to travel. This blend of routine care with innovative technology aims to make prenatal care more accessible and tailored, which could be especially beneficial for those with limited access to healthcare facilities.

What evidence suggests that the StEP:Prenatal intervention might be effective for pregnancy outcomes?

Research shows that the StEP:Prenatal program, available to participants in this trial alongside routine care, may help pregnant women enhance their diet and lifestyle. It delivers health advice remotely, simplifying access to care and support. Studies suggest that remote prenatal programs like StEP:Prenatal can promote healthier eating and increased exercise during pregnancy. Some women report satisfaction with virtual prenatal care, indicating it can match the effectiveness of in-person visits. Overall, early prenatal care, including virtual methods, is linked to better pregnancy outcomes by fostering healthy habits. ^{2 4 5 6 7}

Who Is on the Research Team?

Mary Messito, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking pregnant individuals in their first trimester, who are at least 18 years old and plan to get prenatal and pediatric care at Bellevue Hospital. They must have a smartphone with internet and be able to consent. Those with severe illnesses, living in shelters, or undergoing substance abuse treatment cannot join.

Inclusion Criteria

Currently pregnant in the first trimester (up to 13 weeks, 6 days)

Willing and able to provide consent

Intent to receive prenatal and pediatric care at Bellevue

Exclusion Criteria

Receiving treatment for drug or alcohol use

Living in a shelter

I have a severe illness, such as cancer or epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive routine care and up to 8 StEP:Prenatal sessions remotely

28-42 weeks

Remote sessions

Follow-up

Participants are monitored for diet, lifestyle behaviors, and pregnancy outcomes postpartum

6-14 weeks

Self-reported assessments

What Are the Treatments Tested in This Trial?

Interventions

• StEP:Prenatal

Trial Overview

The study is examining the effectiveness of StEP:Prenatal—a remote program focused on improving diet, lifestyle behaviors, social health factors—and its impact on pregnancy outcomes compared to standard prenatal care.

How Is the Trial Designed?

Group I: Routine Care + StEP:Prenatal Experimental Treatment 2 Interventions

Participants will receive routine care and up to 8 StEP:Prenatal sessions. Routine care will follow through the post-partum period.

Group II: Routine Care Active Control 1 Intervention

Participants will receive routine care during pregnancy and the post-partum period.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Published Research Related to This Trial

The World Health Organization recommends a minimum of eight prenatal visits during pregnancy to ensure high-quality, personalized care, taking into account the sociocultural context of the patients.

The COVID-19 pandemic has necessitated a shift to telemedicine for prenatal care, allowing healthcare professionals to provide consultations remotely, which helps reduce risks for pregnant women while maintaining access to necessary services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pregnancy care during COVID-19 epidemic, a drive for change?] Baena-Antequera, F., Jurado-García, E., Fernández-Carrasco, FJ., et al.[2020]

A review of 13 studies found that both patients and healthcare providers were highly satisfied with virtual prenatal care visits, noting benefits like cost savings and reduced wait times.

There were no significant differences in clinical outcomes between patients using virtual care and those receiving traditional in-person care, suggesting that virtual visits can effectively complement existing prenatal care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Visits in Prenatal Care: An Integrative Review. Wu, KK., Lopez, C., Nichols, M.[2022]

The Virtual Visit model of prenatal care, which combines in-person physician visits with videoconference appointments, does not increase risks for mothers or babies compared to traditional prenatal care, based on a study involving 1,058 low-risk pregnant women.

Women who chose the Virtual Visit track were more likely to be partnered and have previous pregnancies, suggesting this model may be particularly attractive to experienced mothers, while still maintaining similar pregnancy and birth outcomes as traditional care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Visits: Managing prenatal care with modern technology. Pflugeisen, BM., McCarren, C., Poore, S., et al.[2017]

The new Michigan Plan for Appropriate Tailored Healthcare in pregnancy (MiPATH) updates prenatal care recommendations to include individualized care plans, telemedicine integration, and consideration of social and structural determinants of health, reflecting changes in care delivery since the COVID-19 pandemic.

The recommendations aim to improve prenatal care by adjusting the number and frequency of visits and monitoring key pregnancy parameters, ultimately enhancing health outcomes for both pregnant patients and their infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Michigan Plan for Appropriate Tailored Healthcare in Pregnancy Prenatal Care Recommendations: A Practical Guide for Maternity Care Clinicians. Peahl, AF., Turrentine, M., Barfield, W., et al.[2022]

The Strong Start for Mothers and Newborns initiative, launched by the Centers for Medicare and Medicaid Services, aims to reduce preterm births and low-birth-weight infants among Medicaid beneficiaries through public awareness and enhanced prenatal care models.

Alternative prenatal care models, like home visitation and group prenatal care, are being tested and may offer more effective care compared to traditional medical models, particularly for high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strong Start for Mothers and Newborns: implications for prenatal care delivery. Krans, EE., Davis, MM.[2019]

The OB Nest prenatal care model, which includes fewer in-person visits supplemented by virtual connections and home monitoring, aims to maintain or improve patient satisfaction and care continuity for low-risk pregnant women.

This study will evaluate both the effectiveness and feasibility of the OB Nest model compared to standard care, using a mixed-methods approach to gather insights on patient satisfaction, health outcomes, and implementation experiences from both patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study. Ridgeway, JL., LeBlanc, A., Branda, M., et al.[2022]

The PREMOM study, involving 91 participants, showed that mothers, midwives, and obstetricians had positive experiences with remote monitoring for high-risk pregnancies, despite most having little prior experience with the technology.

Nearly 72% of mothers reported no issues with taking measurements, and there was strong support for expanding remote monitoring in prenatal care, highlighting its perceived importance in managing hypertensive disorders during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midwives', Obstetricians', and Recently Delivered Mothers' Perceptions of Remote Monitoring for Prenatal Care: Retrospective Survey. Lanssens, D., Vandenberk, T., Lodewijckx, J., et al.[2020]

A new hybrid low-risk prenatal care protocol was developed for Brazil, combining fewer in-person visits with remote monitoring, which aligns with the Ministry of Health's guidelines.

Pregnant women reported high satisfaction with this hybrid approach, and health outcomes were generally comparable to traditional care, suggesting it could be a safe and effective alternative, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Risk Antenatal Care Enhanced by Telemedicine: A Practical Guideline Model. Colombo, T., Todeschini, LB., Orlandini, M., et al.[2023]

The PREMOM II study involves 3922 pregnant women at risk for gestational hypertensive disorders, comparing the effectiveness of remote monitoring (RM) and self-monitoring against conventional care, aiming to improve prenatal outcomes.

This is the first randomized trial to assess midwife-assisted RM and self-monitoring for prenatal blood pressure, which could lead to new guidelines for managing high-risk pregnancies if positive results are found.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders. Lanssens, D., Thijs, IM., Gyselaers, W.[2021]

A systematic review of 23 studies found that virtual prenatal care is as effective as in-person visits in terms of clinical outcomes, while also offering higher satisfaction rates among pregnant women and healthcare professionals.

Virtual prenatal care significantly reduces travel time and clinic wait times, enhances self-accountability, and is particularly beneficial during situations like a pandemic, making it a valuable option for both low-risk and high-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual prenatal care: A systematic review of pregnant women's and healthcare professionals' experiences, needs, and preferences for quality care. Ghimire, S., Martinez, S., Hartvigsen, G., et al.[2023]

The use of a mobile prenatal care app significantly reduced the average number of in-person obstetric visits for low-risk pregnancies from 10.2 to 7.8 visits, demonstrating its effectiveness in facilitating prenatal care.

Despite the reduction in visits, both patient and provider satisfaction remained unchanged, indicating that the app can maintain quality care while optimizing visit frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. Marko, KI., Ganju, N., Krapf, JM., et al.[2020]

In 2017, 57.4% of health centers met the Healthy People 2020 baseline for early prenatal care initiation, indicating that while many centers are performing well, there is still a significant gap in achieving the target of 84.8%.

Factors positively influencing early prenatal care initiation included having a higher proportion of older and privately insured patients, while negative factors included rural location and a higher number of uninsured patients, highlighting areas for targeted improvement in service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of Prenatal Care Initiation in the Health Resources and Services Administration Health Center Program in 2017. Robbins, C., Martocci, S.[2021]

Low-risk pregnant women in the U.S. traditionally have around 14-16 prenatal visits, but evidence supports a reduced visit schedule without adverse effects on maternal or neonatal outcomes.

The reduced frequency of prenatal visits, proposed by an expert panel in 1989, is a significant consideration for healthcare providers and pregnant women, emphasizing the importance of evidence-based prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based prenatal care visits: when less is more. Walker, DS., McCully, L., Vest, V.[2019]

Citations

1.

portal.nifa.usda.gov

portal.nifa.usda.gov/web/crisprojectpages/1030221-prenatal-starting-early-program-an-mhealth-intervention-in-prenatal-care-and-wic-to-improve-nutrition-and-physical-activity-during-pregnancy.html

An mHealth intervention in prenatal care and WIC to improve ...

Hypothesis 1a: Compared to standard prenatal care, women receiving remote StEP:Prenatal will:Have healthier diet and lifestyle behaviors.

2.

withpower.com

withpower.com/trial/remote-prenatal-care-for-pregnancy-b940d

Remote Prenatal Care for Pregnancy · Info for Participants

Trial Overview The study is examining the effectiveness of StEP:Prenatal—a remote program focused on improving diet, lifestyle behaviors, social health factors— ...

3.

jneb.org

jneb.org/article/S1499-4046(24)00316-6/pdf

An mHealth Intervention in Prenatal Care and WIC to ...

Prenatal Starting Early Program: An mHealth. Intervention in Prenatal Care and WIC to. Improve Nutrition and Physical Activity. During Pregnancy. Mary Jo ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12361639/

Virtual‐Based Prenatal Care Methods and Their Reported ...

Weigel et al. (2020) showed that maternal satisfaction with prenatal care improved or remained unchanged with virtual methods [8]. Quinn et al.

5.

mchevidence.org

mchevidence.org/documents/accelerators/Early-Prenatal-Care-Evidence-Accelerator.pdf

Early Prenatal Care is one of twelve Maternal and Child ...

These strategies support increased access to and utilization of early and adequate prenatal care beginning in the first trimester to improve pregnancy outcomes.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1499404624003166

An mHealth Intervention in Prenatal Care and WIC to ...

Outcomes will include diet, physical activity and pregnancy outcomes, changes in nutrition knowledge among families and WIC nutrition providers, and access and ...

7.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/33/NCT06087133/ICF_000.pdf

Prenatal Starting Early Program: Randomized Controlled Trial of ...

Prenatal Starting Early Program: Randomized Controlled Trial of an mHealth. Intervention in Prenatal Care and WIC to Improve Nutrition and Physical. Activity ...